Patients are followed for disease progression and survival. Patients with HER2-negative
disease are not eligible for treatment but are followed every 6 months for response and
survival.

Inclusion Criteria:

- Histologic diagnosis of urothelial carcinoma (TCC or Squamous) that is either
metastatic or locally recurrent and not curable by surgery or radiation therapy;
patients must have HER2 overexpression as documented by ANY of the following: 1. 2+
or 3+ staining by immunohistochemistry, or 2. a positive FISH score defined as > 2
with the Vysis system or > 4 with the Ventana system, or 3. an elevated serum HER2 of
> 16 ng/ml using the OSDI assay; please note:

- Tissue from either the primary or metastatic site must be tested for HER2 status
determination

- All patients must have a blood sample drawn for HER2 serologic testing

- If the available tissue is from the primary tumor and is HER2 negative and if
the serum is negative, to qualify for the study a biopsy of a metastatic site
should be done and the patient will be eligible ONLY if this demonstrates HER2
over-expression

- All sites and measurements of disease must be clearly documented in the
pre-study forms

- All prior local or adjuvant systemic therapy including the type of chemotherapy
must be clearly documented in the pre-study form Note: Patients with Her-2
negative tumors are not eligible for treatment on this protocol but their
response to other therapy and survival will also be evaluated

- No prior systemic chemotherapy for metastatic disease; patients may have received
adjuvant chemotherapy if completed at least 6 months prior to beginning this protocol
treatment; type and number of courses of prior chemotherapy must be clearly
documented

- A performance status of 0-2 by Southwest Oncology Group criteria and a life
expectancy of greater than 12 weeks

- Serum creatinine =< 2.0 mg%

- Granulocyte count >= 1,500/mm^3

- Platelet >= 100,000/mm^3

- Total bilirubin =< 1.5 mg/dl

- No significant cardiac disease and must have adequate cardiac function (ejection
fraction >= 50% or higher than the lower limit of institutional normal) as determined
by a MUGA scan or 2-D echocardiogram within 4 weeks from registration, and no
evidence of symptomatic coronary artery disease (baseline EKG must show no active
ischemia); patients must not have history of congestive heart failure

- If patients have received prior radiation therapy, disease must be present outside of
radiated fields and at least 4 weeks must have elapsed since discontinuation of that
therapy; the nadirs of RT leukopenia and thrombocytopenia must be surpassed with
evidence of hematologic recovery

- No prior malignancy is allowed, except for adequately treated basal cell (or squamous
cell) skin cancer, in situ carcinoma of any site or other cancer for which the
patient is currently disease free

- Patient may not have unresolved bacterial infection

- Pregnant or lactating women may not participate; this is to avoid potential harm
since the effects of study drugs on the fetus or the nursing infant are not known;
women/men of reproductive potential may not participate unless they have agreed to
use an effective contraceptive method

- HIV -positive patients may not participate; this is to avoid additional complications
that immune suppression and HIV infection may cause due to the intense nature of the
chemotherapy in this trial

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